Cobalamin deficiency in primary care: a placebo-controlled, double-blind, randomized trial
| ISRCTN | ISRCTN22063938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22063938 |
| Protocol serial number | N/A |
| Sponsor | Medical Outpatient Clinic, University of Lausanne (Switzerland) |
| Funder | Medical Outpatient Clinic, University of Lausanne |
- Submission date
- 29/12/2005
- Registration date
- 20/02/2006
- Last edited
- 27/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bernard Favrat
Scientific
Scientific
Bugnon 44
Lausanne
1011
Switzerland
| Phone | +41 (0)21 314 4906 |
|---|---|
| bernard.favrat@hospvd.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo-controlled, double-blind, randomized trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the clinical and biological impact of oral vitamin B12 therapy among patients with a serum vitamin B12 level below 200 pmole/l |
| Ethics approval(s) | The study was approved by the Ethical Review Committee for Clinical Research, Department of Internal Medicine, University of Lausanne, Switzerland |
| Health condition(s) or problem(s) studied | Cobalamin deficiency |
| Intervention | Oral vitamin B12 versus placebo |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Evolution of biological markers (serum vitamin B12 level, serum methymalonic acid and homocystein levels) |
| Key secondary outcome measure(s) |
Clinical evolution (hematologic, neurologic, psychiatric) |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Patients suspected of cobalamin deficiency with serum vitamin B12 level between 125 and 200 pmole/l. Patients with serum vitamin B12 level below 125 pmole/l were followed-up openly with oral cobalamin. |
| Key exclusion criteria | Unwillingness to participate |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bugnon 44
Lausanne
1011
Switzerland
1011
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/01/2011 | Yes | No |
